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Acceleron's (XLRN) PAH Candidate Gets Orphan Designation in EU
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Acceleron Pharma Inc. announced that the European Commission has granted Orphan Designation to its investigational pipeline candidate, sotatercept for the treatment of patients with pulmonary arterial hypertension (“PAH”), a rare disease of high unmet medical need.
In the EU, an Orphan status is given to products targeting a life-threatening or chronically debilitating rare disease that affects fewer than 5 in 10,000 individuals for which no suitable treatment is available.
Shares of Acceleron were up 4.6% following this news on Monday. In fact, so far this year, the stock has skyrocketed 145.2% compared with the industry’s increase of 7.1%.
We remind investors that in September 2019, sotatercept received an Orphan Drug tag in the United States for the treatment of PAH. The candidate also received a Breakthrough Therapy designation from the FDA for the same indication in April 2020.
Meanwhile, the European Medicines Agency bestowed a Priority Medicines (PRIME) designation to sotatercept for PAH in May 2020.
Please note that sotatercept is being developed as part of Acceleron’s licensing agreement with Bristol Myers Squibb (BMY - Free Report) .
Sotatercept is currently being evaluated in several mid-to-late-stage studies for treating PAH. The phase II PULSAR study, which evaluated sotatercept in combination with approved PAH-specific medicines, met its primary endpoint in patients with PAH as well key secondary endpoints. Meanwhile, enrollment is also ongoing in an exploratory phase II study SPECTRA to understand sotatercept's potential impact on PAH with additional results expected in the first half of 2021.
Acceleron is currently planning to begin multiple phase III studies to support its long-term vision of establishing sotatercept as a backbone therapy for patients with PAH at all stages of the disease.
The company plans to initiate a phase III registrational STELLAR study on sotatercept in patients with PAH by 2020-end. The company also expects to begin the HYPERION (early intervention) phase III study and the ZENITH (later intervention) phase III study in PAH patients in the middle of 2021.
Repligen’s earnings estimates have moved 12.5% and 16.9% north for 2020 and 2021, respectively, over the past 60 days. The stock has rallied 99% year to date.
Aptose Biosciences’ loss per share estimate has been narrowed 10.3% for 2020 and 4.7% for 2021 over the past 60 days.
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Acceleron's (XLRN) PAH Candidate Gets Orphan Designation in EU
Acceleron Pharma Inc. announced that the European Commission has granted Orphan Designation to its investigational pipeline candidate, sotatercept for the treatment of patients with pulmonary arterial hypertension (“PAH”), a rare disease of high unmet medical need.
In the EU, an Orphan status is given to products targeting a life-threatening or chronically debilitating rare disease that affects fewer than 5 in 10,000 individuals for which no suitable treatment is available.
Shares of Acceleron were up 4.6% following this news on Monday. In fact, so far this year, the stock has skyrocketed 145.2% compared with the industry’s increase of 7.1%.
We remind investors that in September 2019, sotatercept received an Orphan Drug tag in the United States for the treatment of PAH. The candidate also received a Breakthrough Therapy designation from the FDA for the same indication in April 2020.
Meanwhile, the European Medicines Agency bestowed a Priority Medicines (PRIME) designation to sotatercept for PAH in May 2020.
Please note that sotatercept is being developed as part of Acceleron’s licensing agreement with Bristol Myers Squibb (BMY - Free Report) .
Sotatercept is currently being evaluated in several mid-to-late-stage studies for treating PAH. The phase II PULSAR study, which evaluated sotatercept in combination with approved PAH-specific medicines, met its primary endpoint in patients with PAH as well key secondary endpoints. Meanwhile, enrollment is also ongoing in an exploratory phase II study SPECTRA to understand sotatercept's potential impact on PAH with additional results expected in the first half of 2021.
Acceleron is currently planning to begin multiple phase III studies to support its long-term vision of establishing sotatercept as a backbone therapy for patients with PAH at all stages of the disease.
The company plans to initiate a phase III registrational STELLAR study on sotatercept in patients with PAH by 2020-end. The company also expects to begin the HYPERION (early intervention) phase III study and the ZENITH (later intervention) phase III study in PAH patients in the middle of 2021.
Zacks Rank & Stocks to Consider
Acceleron currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector include Repligen Corporation (RGEN - Free Report) and Aptose Biosciences, Inc. (APTO - Free Report) , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Repligen’s earnings estimates have moved 12.5% and 16.9% north for 2020 and 2021, respectively, over the past 60 days. The stock has rallied 99% year to date.
Aptose Biosciences’ loss per share estimate has been narrowed 10.3% for 2020 and 4.7% for 2021 over the past 60 days.
Legal Marijuana: An Investor’s Dream
Imagine getting in early on a young industry primed to skyrocket from $17.7 billion in 2019 to an expected $73.6 billion by 2027.
Although marijuana stocks did better as the pandemic took hold than the market as a whole, they’ve been pushed down. This is exactly the right time to get in on selected strong companies at a fraction of their value before COVID struck. Zacks’ Special Report, Marijuana Moneymakers, reveals 10 exciting tickers for urgent consideration.
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